Advancing Regulatory Science for Medical Countermeasure Development. Workshop Summary

摘要

In August 2010, the U.S. Department of Health and Human Services (HHS) released its review of the Public Health Emergency Medical Coun-termeasures Enterprise (PHEMCE) and made numerous recommenda-tions to transform the MCM enterprise to increase its speed, agility, capac-ity, and success rate, including the promotion of regulatory innovation and investment in regulatory science at FDA (ASPR, 2010).2 In this regard, FDA has established an MCM initiative that includes (1) enhancing the regulatory review process for the highest-priority MCMs and related technologies; (2) advancing regulatory science to support MCM development and evaluation; and (3) modernizing the legal and regulatory framework to support public health preparedness and response.